Clin Trials Rsrch Asst/Data Mg - ICTS Coordinator Core

University of Iowa • Iowa City, IA

10d • Onsite

About The Position

The Institute for Clinical and Translational Science (ICTS) is seeking a Clinical Trial Research Assistant/Data Manager to join the ICTS Coordinator Core as an integral member of our research team. This position provides essential research support by performing activities critical to advancing the ICTS research mission, strengthening research infrastructure, and fostering innovation through collaborative research support. The successful candidate will apply clinical and research skills to administer, coordinate, deliver, and evaluate clinical research protocols while supporting investigators and study teams across a portfolio of clinical trials.

Requirements

• A Bachelor’s degree in a Health Science field or an equivalent combination of education and research experience.
• Excellent written and verbal communication skills.
• Ability to work nights and weekends.
• Proficiency in Microsoft Word, Outlook and Excel.

Nice To Haves

• Basic clinical research experience.
• Working knowledge of Good Clinical Practice (GCP).
• Previous experience writing manuscripts for publication.
• Experience with REDCap, Epic, I-CART, and ACCESS.
• Previous experience in data collection and entry.
• Experience in processing research regulatory documents.
• A current license to practice nursing in Iowa by the time of hire.
• The ability to work independently.
• Excellent time management skills and ability to perform detail-oriented work.

Responsibilities

• Perform clinical/health care research activities in various departments
• Screen, recruit, enroll and obtain informed consent for clinical research activities
• Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient.
• Relay information to principal investigator and verify patient eligibility.
• Administer study treatments and report adverse reactions.
• Oversee the recruitment of subjects and scheduling of trial-related procedures.
• Prepare study recruitment materials.
• Assist in the design, development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.
• Assist patients with problems related to protocol.
• Oversee CRF development and database development and maintenance.
• Review query reports. Resolve all monitoring visit issues.
• Perform and monitor randomizations.
• Develop complex study materials.
• Serve as liaison to local health care practitioners, agencies, and sponsors.
• Participate in the design; development and testing of clinical research trial data systems.
• Acts as a liaison between health care clinical information systems and research data systems.
• Validate data and make recommendations for resolution.
• Manage and organize regulatory documentation.
• Prepare regulatory submissions.
• Perform on-site audits of research and clinical data.
• Monitor compliance of regulatory guidelines and proper maintenance of documents.
• Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
• Assist with IRB, ACURF or similar protocol submissions.
• Participate in preparation of grant applications for extramural funding.
• Provide assistance with tracking and reconciling grant/trial budget free balances and identify opportunities to ensure that grant funding is being used as intended and awarded.

Benefits

• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level